Attorneys familiar with dietary supplements who were contacted by NutraIngredients-USA said the move toward personalization could open some new cans of legal worms. Of particular concern, they said, was how a company gathered the information from its customers that would inform how the ‘personalized’ products would be put together.
The data that could be used in this endeavor range from answers to fairly generic questionnaires, to genomic testing, blood draws and other biometric measurements like blood pressure, even microbiome testing. Right now personalization in dietary supplements seems to be more of an interest on the part of marketers and product formulators as opposed to a real force in the marketplace. But if the concept gets hot and starts to result in some major sales, one could foresee companies starting to compete on who gathers the best and most complete suite of information from consumers. If one continues a long way down that path, well, as medieval geographers used to say to the early explorers: There be monsters.
“In so far as these products are based on an analysis that purports to give the consumer just the right supplements, in that sense it’s related to a claim, and manufacturers are always responsible for claims,” Ivan Wasserman, a partner in the firm Amin Talati Upadhye told NutraIngredients-USA. What, in other words, is your backing for the implied claim that this process of data gathering will result in a product that performs better for the individual consumer? This idea makes objective sense, but as yet there is little hard evidence to support it.
“If they state expressly or imply that their supplement regimens are superior to others because they are personally tailored, if they don’t have substantiation to prove that, they potentially could be challenged on that by regulators or by consumer litigation,” he said.
Avoiding implied disease claims
Justin Prochnow, a shareholder in the firm Greenberg Traurig, said that companies would have to be careful in how they collected the data from consumers. The problems the genomic testing company 23-and-Me ran into with FDA show that the agency is keeping a close watch on how data-driven companies are interacting with consumers. The more specific the data a personalized nutrition company might gather in its zeal to make the best performing product for a consumer, the closer it might unwittingly step toward the line of making a drug claim. At the core of the whole issue is, how much better could a personalized supplement perform than a middle of the road formulation before it starts to leave the supplement world and starts to become a drug?
“That implies the whole caveat that you have to keep things to supporting or maintaing a healthy constitution. Even with a simple questionnaire, you can’t ask things that might imply that you intend to treat or prevent an illness. When you start asking things like if there is a family history of heart disease, now you could start to get a halo that you are somehow trying to prevent that from happening,” Prochnow said.
FDA was the protagonist in the tussle with 23 and Me over whether that company’s first generation genomic testing kit, which provided results pertaining to disease risks and drug interactions, amounted to an unapproved medical device (the company has since ratcheted back the information it provides to its consumers). But Prochnow said there are more sheriffs in town now than there used to be.
“Your biggest risk in this day and age is the FTC or state attorneys general or even the local district attorney. They are going to send you a letter demanding substantiation for the claims you are making about how your system works, especially when this is a new or novel way of marketing supplements that nobody has seen before,” Prochnow said.
Being clear about degree of personalization
Wasserman said that with the risk of perhaps being seen as having over promised about how good personalized supplement would be, under delivering is a risk, too. The program has to be communicated in a clear way, much as claims of health benefits of a supplement should be closely matched to what the underlying science says. If your personalization program is really a way to direct a consumer to one of several products, rather than creating a unique formulation just for them, that should be clear to the consumer.
“If the message is that you are really tailoring the product when in fact you are just choosing from three or four different buckets, you may be accused of deceptively overstating the degree of personalization. If it is clear to the consumer that they will get one of several different available regimens, the issue is more clear,” he said.
Prochnow said those kind of over promise-under deliver scenarios are the stuff of plaintiffs’ lawyers dreams, especially in a situation where the defendant might not have ironclad scientific evidence to offer in defense.
“Whether a plaintiffs’ lawyer could actually win those cases seems to be irrelevant. Most of them are just looking for a quick settlement,” he said.